{"abstract":"The Food and Drug Administration (FDA, the Agency, we) is issuing a final rule that establishes procedures by which we may establish, amend, or revoke tolerances for residues of new animal drugs in any edible portion of any animal imported into the United States (import tolerances). These import tolerances provide a basis for the legal marketing of such animal-derived food.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/09/21/2021-19967.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"10","title":21},{"chapter":null,"citation_url":null,"part":"20","title":21},{"chapter":null,"citation_url":null,"part":"25","title":21},{"chapter":null,"citation_url":null,"part":"500","title":21},{"chapter":null,"citation_url":null,"part":"510","title":21}],"citation":"86 FR 52401","comment_url":null,"comments_close_on":"2021-10-21","correction_of":null,"corrections":[],"dates":"This rule is effective January 19, 2022. Submit written comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by October 21, 2021 (see section IX, the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2001-N-0075 (formerly Docket No. 2001N-0284)"],"dockets":[{"supporting_documents":[{"title":"Tab C Updated Changes to FRN Draft by OIRA re: Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0020"},{"title":"Tab B Changes to Draft Submitted by OIRA re: Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0019"},{"title":"Tab A Copy of Draft Regulatory Action (OMB Review) re: Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0018"},{"title":"Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0017"}],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2021-09-21","updated_at":"2023-02-28T17:21:26.389-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2001-N-0075-0027","allow_late_comments":null,"id":"FDA-2001-N-0075-0027","comment_end_date":"2021-10-22","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2001-N-0075","title":"Regulation for establishing import tolerances"}],"document_number":"2021-19967","effective_on":"2022-01-19","end_page":52412,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/09/21/2021-19967.xml","html_url":"https://www.federalregister.gov/documents/2021/09/21/2021-19967/import-tolerances-for-residues-of-unapproved-new-animal-drugs-in-food","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-19967?publication_date=2021-09-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-09-21/2021-19967/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":3622,"last_updated":"2026-07-28 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-09-21/pdf/2021-19967.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-19967.pdf?1632141920","publication_date":"2021-09-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/09/21/2021-19967.txt","regulation_id_number_info":{"0910-AF78":{"issue":"202104","html_url":"https://www.federalregister.gov/regulations/0910-AF78/import-tolerances-for-residues-of-unapproved-new-animal-drugs-in-food","title":"Import Tolerances for Residues of Unapproved New Animal Drugs in Food","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-AF78&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AF78"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab C Updated Changes to FRN Draft by OIRA re: Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0020"},{"title":"Tab B Changes to Draft Submitted by OIRA re: Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0019"},{"title":"Tab A Copy of Draft Regulatory Action (OMB Review) re: Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0018"},{"title":"Executive Order 12866 Regulatory Review re: Import Tolerances; Advance Notice of Proposed Rulemaking; FRN 66FR42167","document_id":"FDA-2001-N-0075-0017"}],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2001-N-0075","supporting_documents_count":4,"docket_id":"FDA-2001-N-0075","document_id":"FDA-2001-N-0075-0027","regulation_id_number":null,"title":"Regulation for establishing import tolerances","checked_regulationsdotgov_at":"2023-02-28T22:21:25Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":52401,"subtype":null,"title":"Import Tolerances for Residues of Unapproved New Animal Drugs in Food","toc_doc":"Import Tolerances for Residues of Unapproved New Animal Drugs in Food","toc_subject":null,"topics":["Administrative practice and procedure","Animal drugs","Cancer","Confidential business information","Courts","Environmental impact statements","Foreign relations","Freedom of information","Government employees","Labeling","News media","Packaging and containers","Polychlorinated biphenyls (PCB's)","Reporting and recordkeeping requirements"],"type":"Rule","volume":86}